Effects of Caffeinated Beverages on Well-being

GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.

Status: Enrolling

Conditions: Caffeine; Healthy; Beverage Intake

Treatments: Other: Participants' typical caffeinated beverage; Other: Test caffeinated beverage

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07357818

NL-2502

Details and patient eligibility

About

This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverages in generally healthy adults.

Full description

This will evaluate post-beverage subjective caffeine responses using visual analog scale questionnaires, mood, quality of life, and physiological responses to caffeine beverages compared to participants' habitual caffeine beverage intake in generally healthy adults.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males or females, ≥18 to ≤55 years of age
2. BMI ≥18.5 and <29.9 kg/m2
3. Generally good health
4. Participant currently and consistently has a caffeine routine
5. Participant is willing to substitute their current caffeine routine for the test beverage daily
6. Participant has never consumed the test beverage or similar products
7. Participant currently owns a wearable and is willing to use and connect the wearable device
8. Willing to use personal smart phone, tablet, or personal computer with stable internet connection
9. Willing and able to comply with all study procedures
10. Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study

Exclusion criteria

1. History or presence, on the basis of the health history, of clinically important condition or disease states
2. Is currently following, or planning to be on, a weight loss regimen
3. Weight loss or gain >4.5 kg
4. History of gastrointestinal surgery for weight reducing purposes or gastrointestinal (GI) conditions
5. History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
6. History of unconventional sleep patterns (e.g., night shift) or diagnosed sleep disorder
7. Use of tobacco/nicotine products
8. Use of hemp/marijuana products
9. Unstable use of any prescription medication
10. Use of any medications(s) or dietary supplement(s), containing caffeine, or interacting with caffeine
11. Recent history of alcohol or substance abuse
12. Exposed to any non-registered drug product
13. Self-report of hypertension/high blood pressure without use of hypertensive medications
14. Any known allergy or intolerance to any ingredients contained in the study product
15. Any signs or symptoms of active infection of clinical relevance
16. History or presence of cancer, except for non-melanoma skin cancer
17. History of any major trauma or major surgical event
18. Female who is pregnant, planning to be pregnant during the study period, lactating
19. An employee, close relative of an employee, or participant who has a financial interest in Sponsor company or any other caffeine beverage company.
20. Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol
21. A clinically significant medical condition that is affected by caffeine

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Test caffeinated beverage followed by participants' typical caffeinated beverage

Other group

Treatment:

Other: Test caffeinated beverage

Other: Participants' typical caffeinated beverage

Participants' typical caffeinated beverage followed by test caffeinated beverage

Other group

Treatment:

Other: Test caffeinated beverage

Other: Participants' typical caffeinated beverage